Randomized Controlled Trial of Integrated Early Palliative Care

Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Cancer Patients

This study verifies whether integrated Early Palliative Care for advanced cancer patients diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome the current crisis.

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Advanced Cancer
• Intervention / Treatment: Behavioral: Telephone coaching; Behavioral: Consultation with PCT doctor

Detailed Description

Previous reports suggest that starting palliative care early in cancer patients appears to improve patient's quality of life, symptom management, depression, and anxiety.

This study aims to evaluate the effect of the introduction of early palliative care services to advanced cancer patients. Eligible patients are 20 years or older, and has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor, a European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months or less. The primary goal of an integrated early palliative care program is to improve the overall quality of life of patients and their families. Secondarily, it is to help understand the disease, resolving conflicts in the decision-making process, improving the crisis coping capacity, and further determining the patient's and family's advanced care planning. At last, it is desired to evaluate the effect of the program on overall medical cost savings and 1 year survival.

Participants of the study will be allocated in the intervention group and the control group equally. Within three weeks from the time of randomization, the first meeting with a palliative care team will be held. In the time of baseline questionnaire, patients will be provided with self-study education materials and videos on the early palliative care and advance care planning. Once in every three weeks for six months, which is the duration for one treatment course, palliative care for advance care planning, symptom control, and other mental, social and spiritual problems will be provided. After the first meeting with the palliative care team, telephone coaching will be performed once a week for the first 12 weeks and then every two weeks until the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Gyeongsangnam-do
    • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
      • Gyeongsang National University Hospital
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Chonbuk National University Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject 20 years and older.
• Subject who has an advanced cancer diagnosis (histologically or cytologically confirmed) due to a solid tumor
• Subject whose ECOG performance status is between 0 to 2.
• Subject with an estimated life expectancy of 12 months and less (assessed by the treating oncologist)
• Subject who volunteers

Exclusion Criteria:

• Inability to speak, understand or write Korean.
• Medical conditions that would limit adherence to participation of the clinical trial(as confirmed by their referring physician; e.g. dyspnea)
• Suspension of all cancer treatment
• Palliative care consultation at any time or in palliative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Consultation with PCT doctor every 3 weeks. Telephone coaching once a week for 3 months and once in 2 weeks for another 3 months.	Behavioral: Telephone coaching; Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.; Behavioral: Consultation with PCT doctor; Consultation with PCT physician every 3 weeks.
NO_INTERVENTION: Control Group; Usual palliative care can be provided if desired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of EORTC QLQ-C15-PAL	A questionnaire developed to assess the quality of life of palliative cancer care patients.	baseline, 12 weeks, 18 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of MQOL	A questionnaire that measures psychological, existential well-being, and support.	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of EQ-5D of EuroQoL	A questionnaire that measures mobility, self-care, daily activity, pain/discomfort, and anxiety/depression.	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of PHQ-9	9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression.	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Understanding the illness	2 questions to assess how patients understand the prognosis of their illness	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Crisis Overcoming Capability(SAT-SF)	A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice.	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Advance Care Preference	Questions about advance directive and treatment preference in case of terminal condition	Baseline, 12 weeks, 18 weeks, 24 weeks
Medical cost and utilization of CAM	Overall medical cost savings (cost effectiveness) and use of complementary and alternative medicine	12 weeks, 24 weeks
1 year survival	1 year survival	1 year
Changes of CQOL	A questionnaire that measures quality of life and burden for family caregivers	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of PHQ-9 of family caregivers	9-question instrument given to caregivers in a primary care setting to screen for the presence and severity of depression.	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Understanding the illness of family caregivers	2 questions to assess how family caregivers understand the prognosis of patients' illness	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in level of Crisis Overcoming Capability(SAT-SF) of family caregivers	A questionnaire about goal of life, current crisis/goal, positivity, preparation and practice of family caregivers.	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Advance Care Preference of family caregivers	Questions about family caregivers' preference on advance directive and treatment in case of terminal condition	Baseline, 12 weeks, 18 weeks, 24 weeks
Change in Quality Care Questionnaire	The 4-factor, 32-item Quality Care Questionnaire-Palliative Care (QCQ-PC), which covers appropriate communication with health care professionals (ten items), discussing value of life and goals of care (nine items), support and counseling for needs of holistic care (seven items), and accessibility and sustainability of care (six items).	Baseline, 12 weeks, 3 months after death

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Chonbuk National University Hospital; Asan Medical Center; Chonnam National University Hospital; Ulsan University Hospital; Seoul National University Bundang Hospital; Korea University Guro Hospital; Gyeongsang National University Hospital; Severance Hospital; Ewha Womans University Mokdong Hospital; Keimyung University Dongsan Medical Center; Hallym University Medical Center; Chungnam National University Hospital; National Evidence-Based Healthcare Collaborating Agency; National Clinical Research Coordination Center, Seoul, Korea; National Institute of Health, Korea; Gangneung Asan Hospital; Daegu Fatima Hospital; Pohang Semyeong Christianity Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2017
• Primary Completion (ACTUAL): October 24, 2018
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (ACTUAL): June 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Integrated Early Palliative Care
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HC15C1391-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No